ATRS: IND Application for Adrenal Crisis Rescue
Jun 22, 2021 13:05:31 GMT
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Post by icemandios on Jun 22, 2021 13:05:31 GMT
Antares Pharma Announces Submission of IND Application for ATRS-1902 for Adrenal Crisis Rescue
EWING, N.J., June 22, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a specialty pharmaceutical company, today announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical study of ATRS-1902 for adrenal crisis rescue. The IND application for ATRS-1902, and its corresponding development program, supports a proposed indication for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using a novel proprietary auto-injector platform to deliver hydrocortisone.
“Adrenal crisis is a potentially fatal condition associated mainly with an acute deficiency of cortisol, which is a hormone produced and released by the adrenal gland, and commonly occurs in patients with long-term adrenal insufficiency. It is estimated that primary adrenal insufficiency, or Addison’s disease, affects approximately 100 to 140 of every million people ( 1 ) . Secondary adrenal insufficiency is more common, affecting approximately 150 to 280 people per million ( 2)(3) ,” commented Dr. Peter Richardson, EVP, Research and Development and Chief Medical Officer of Antares Pharma.
Current standard of care for the management of acute adrenal crises includes Solu-Cortef ® , which is an anti-inflammatory glucocorticoid. With hydrocortisone sodium succinate as the active ingredient, Solu-Cortef ® is provided as a sterile powder that needs to be reconstituted for intravenous or intramuscular injection and can represent a time-consuming and cumbersome injection process, particularly challenging in a crisis situation.
Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, “This IND submission represents a key milestone for Antares as we continue to advance our proprietary pipeline. With a novel expansion to our device technology platforms, we believe ATRS-1902 could potentially offer a better solution for patients in need of rescue therapy compared to current standard of care. Positive results from an initial user study and payer survey further highlight the key advantages and opportunity for this rescue therapy. We look forward to providing more detail on the timeline and market opportunity following FDA acceptance of the IND.”
Following written feedback from the FDA at a Pre-IND meeting, the IND application for ATRS-1902 includes a proposed protocol for an initial clinical study to compare the pharmacokinetic profile of our novel formulation of hydrocortisone versus Solu-Cortef ® . The FDA will review our IND application and determine the acceptability of the submission before Antares can commence the proposed phase 1 trial for ATRS-1902. After this study is completed, a second study will then be conducted utilizing our proprietary auto-injector technology which has been developed for high reliability and ease-of-use in emergency situations by the patient or caregiver. We believe these two studies will be the basis of our anticipated 505(b)(2) NDA filing with the FDA towards the end of 2022.
(1) Bornstein SR, Allolio B, Arlt W, et al. Diagnosis and treatment of primary adrenal insufficiency: an Endocrine Society clinical practice guideline. The Journal of Clinical Endocrinology and Metabolism. 2016;101(2):364–369.
(2) Charmandari E, Nicolaides NC, Chrousos GP. Adrenal insufficiency. Lancet. 2014;383(9935):2152–2167.
(3) Chabre O, Goichot B, Zenaty D, Bertherat J. Group 1. Epidemiology of primary and secondary adrenal insufficiency: prevalence and incidence, acute adrenal insufficiency, long-term morbidity and mortality. Annals of Endocrinology (Paris). 2017;78(6):490–494.
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma’s FDA-approved products include XYOSTED ® (testosterone enanthate) injection, OTREXUP ® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA ® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.
EWING, N.J., June 22, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a specialty pharmaceutical company, today announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical study of ATRS-1902 for adrenal crisis rescue. The IND application for ATRS-1902, and its corresponding development program, supports a proposed indication for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using a novel proprietary auto-injector platform to deliver hydrocortisone.
“Adrenal crisis is a potentially fatal condition associated mainly with an acute deficiency of cortisol, which is a hormone produced and released by the adrenal gland, and commonly occurs in patients with long-term adrenal insufficiency. It is estimated that primary adrenal insufficiency, or Addison’s disease, affects approximately 100 to 140 of every million people ( 1 ) . Secondary adrenal insufficiency is more common, affecting approximately 150 to 280 people per million ( 2)(3) ,” commented Dr. Peter Richardson, EVP, Research and Development and Chief Medical Officer of Antares Pharma.
Current standard of care for the management of acute adrenal crises includes Solu-Cortef ® , which is an anti-inflammatory glucocorticoid. With hydrocortisone sodium succinate as the active ingredient, Solu-Cortef ® is provided as a sterile powder that needs to be reconstituted for intravenous or intramuscular injection and can represent a time-consuming and cumbersome injection process, particularly challenging in a crisis situation.
Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, “This IND submission represents a key milestone for Antares as we continue to advance our proprietary pipeline. With a novel expansion to our device technology platforms, we believe ATRS-1902 could potentially offer a better solution for patients in need of rescue therapy compared to current standard of care. Positive results from an initial user study and payer survey further highlight the key advantages and opportunity for this rescue therapy. We look forward to providing more detail on the timeline and market opportunity following FDA acceptance of the IND.”
Following written feedback from the FDA at a Pre-IND meeting, the IND application for ATRS-1902 includes a proposed protocol for an initial clinical study to compare the pharmacokinetic profile of our novel formulation of hydrocortisone versus Solu-Cortef ® . The FDA will review our IND application and determine the acceptability of the submission before Antares can commence the proposed phase 1 trial for ATRS-1902. After this study is completed, a second study will then be conducted utilizing our proprietary auto-injector technology which has been developed for high reliability and ease-of-use in emergency situations by the patient or caregiver. We believe these two studies will be the basis of our anticipated 505(b)(2) NDA filing with the FDA towards the end of 2022.
(1) Bornstein SR, Allolio B, Arlt W, et al. Diagnosis and treatment of primary adrenal insufficiency: an Endocrine Society clinical practice guideline. The Journal of Clinical Endocrinology and Metabolism. 2016;101(2):364–369.
(2) Charmandari E, Nicolaides NC, Chrousos GP. Adrenal insufficiency. Lancet. 2014;383(9935):2152–2167.
(3) Chabre O, Goichot B, Zenaty D, Bertherat J. Group 1. Epidemiology of primary and secondary adrenal insufficiency: prevalence and incidence, acute adrenal insufficiency, long-term morbidity and mortality. Annals of Endocrinology (Paris). 2017;78(6):490–494.
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma’s FDA-approved products include XYOSTED ® (testosterone enanthate) injection, OTREXUP ® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA ® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.